The Combination of Anti-PD-1 With Radiotherapy in Previously Untreated Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT04017897|
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Currently, the first line treatment options for surgically unresectable metastatic melanoma includes anti-PD1 agents such as nivolumab and pembrolizumab. In western countries, UV associated cutaneous melanoma has 30-40% response rates to immune checkpoint inhibitors (ICIs). However, response rates are lower in Asians. The reason for this discrepancy is attributed to the difference in subtypes since most of the Asian patients are mostly subgrouped as acral lentiginous or mucosal types that are unrelated to UV exposures. Thus, there is an unmet need to bolster the effect of ICIs in these patients.
The combination of radiotherapy with ICIs have been demonstrated by several pre-clinical studies. High dose radiation has shown to promote STING pathway which activates dendritic cells needed in priming phase. In addition, low dose radiation may activate macrophage differentiation. These mechanisms in turn may enhance responses to immunotherapy.
In this study, the investigators aim to evaluate the efficacy and tolerability of anti-PD-1 blockade in combination with radiotherapy in surgically unresectable, treatment naive metastatic melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: The combination of radiotherapy with anti-PD1 (pembrolizumab or nivolumab)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Combination of Anti-PD-1 With Radiotherapy in Previously Untreated Metastatic Melanoma|
|Actual Study Start Date :||July 3, 2019|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
Drug: The combination of radiotherapy with anti-PD1 (pembrolizumab or nivolumab)
Subjects with treatment naïve, surgically unresectable metastatic melanoma stages IIIB to IVM1c will be treated with combination of anti-PD1 (pembrolizumab or nivolumab) and radiotherapy.
- Overall response rate (ORR) [ Time Frame: 1 year ]assessment of efficacy of anti-PD1 with radiotherapy in terms of overall response rate (ORR)
- treatment-related adverse events (TRAE) [ Time Frame: 3 years ]
- rate of progression-free survival (PFS) [ Time Frame: 1 year ]
- overall survival (OS) [ Time Frame: 1 year ]
- disease control rate (DCR) [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017897
|Contact: Sang Joon Shin, MD, Ph.Demail@example.com|
|Korea, Republic of|
|Department of Surgery, Yonsei University College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Sang-Joon Shin, MD, Ph.D 82-2-2228-8138 firstname.lastname@example.org|